A Study to Evaluate SAGE-217 in Adult Participants With Major Depressive Disorder (MDD)

A Phase 3, Open-Label, 1-Year Study of the Safety, Tolerability, and Need for Re-Treatment With SAGE-217 in Adult Subjects With Major Depressive Disorder

This is a Phase 3, open-label, 1-year study of the safety, tolerability, and need for re-treatment with SAGE-217 in adult participants with MDD.

Study Overview

• Status: Completed
• Conditions: Major Depressive Disorder
• Intervention / Treatment: Drug: SAGE-217

Detailed Description

This study was previously posted by Sage Therapeutics. In July 2024, sponsorship of the trial was transferred to Biogen.

• Study Type: Interventional
• Enrollment (Actual): 1515
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Dothan, Alabama, United States, 36303
      • Sage Investigational Site
  • Arizona
    • Phoenix, Arizona, United States, 85012
      • Sage Investigational Site
  • California
    • Anaheim, California, United States, 92805
      • Sage Investigational Site
    • Costa Mesa, California, United States, 92626
      • Sage Investigational Site
    • Glendale, California, United States, 91206
      • Sage Investigational Site
    • Irvine, California, United States, 92614
      • Sage Investigational Site
    • Los Alamitos, California, United States, 90720
      • Sage Investigational Site
    • Oceanside, California, United States, 92056
      • Sage Investigational Site
    • Orange, California, United States, 92868
      • Sage Investigational Site
    • Riverside, California, United States, 92503
      • Sage Investigational Site
    • San Diego, California, United States, 92103
      • Sage Investigational Site
    • Temecula, California, United States, 92591
      • Sage Investigational Site
  • Colorado
    • Colorado Springs, Colorado, United States, 80910
      • Sage Investigational Site
  • Connecticut
    • Cromwell, Connecticut, United States, 06416
      • Sage Investigational Site
    • Norwich, Connecticut, United States, 06360
      • Sage Investigational Site
  • Florida
    • Coral Springs, Florida, United States, 33067
      • Sage Investigational Site
    • Jacksonville, Florida, United States, 32256
      • Sage Investigational Site
    • Miami, Florida, United States, 33122
      • Sage Investigational Site
    • Orlando, Florida, United States, 32807
      • Sage Investigational Site
    • Orlando, Florida, United States, 32801
      • Sage Investigational Site
    • Pensacola, Florida, United States, 32502
      • Sage Investigational Site
  • Georgia
    • Alpharetta, Georgia, United States, 30022
      • Sage Investigational Site
    • Atlanta, Georgia, United States, 30331
      • Sage Investigational Site
    • Marietta, Georgia, United States, 30060
      • Sage Investigational Site
    • Savannah, Georgia, United States, 31405
      • Sage Investigational Site
  • Illinois
    • Chicago, Illinois, United States, 60634
      • Sage Investigational Site
    • Chicago, Illinois, United States, 60640
      • Sage Investigational Site
  • Massachusetts
    • Watertown, Massachusetts, United States, 02472
      • Sage Investigational Site
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Sage Investigational Site
  • Missouri
    • Saint Charles, Missouri, United States, 63304
      • Sage Investigational Site
  • Nebraska
    • Lincoln, Nebraska, United States, 68526
      • Sage Investigational Site
  • New Jersey
    • Cherry Hill, New Jersey, United States, 08002
      • Sage Investigational Site
    • Marlton, New Jersey, United States, 08053
      • Sage Investigational Site
    • Princeton, New Jersey, United States, 08540
      • Sage Investigational Site
  • New Mexico
    • Albuquerque, New Mexico, United States, 87109
      • Sage Investigational Site
  • New York
    • Brooklyn, New York, United States, 11229
      • Sage Investigational Site
    • Brooklyn, New York, United States, 11235
      • Sage Investigational Site
    • Mount Kisco, New York, United States, 10549
      • Sage Investigational Site
  • Ohio
    • Beachwood, Ohio, United States, 44122
      • Sage Investigational Site
    • Cincinnati, Ohio, United States, 45212
      • Sage Investigational Site
    • Cincinnati, Ohio, United States, 45215
      • Sage Investigational Site
    • Cincinnati, Ohio, United States, 45219
      • Sage Investigational Site
    • North Canton, Ohio, United States, 44720
      • Sage Investigational Site
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • Sage Investigational Site
  • Pennsylvania
    • Plymouth Meeting, Pennsylvania, United States, 19462
      • Sage Investigational Site
  • Texas
    • Austin, Texas, United States, 78759
      • Sage Investigational Site
    • Dallas, Texas, United States, 75231
      • Sage Investigational Site
    • Houston, Texas, United States, 77030
      • Sage Investigational Site
    • Houston, Texas, United States, 77081
      • Sage Investigational Site
    • Newport, Texas, United States, 78712
      • Sage Investigational Site
    • Wichita Falls, Texas, United States, 76309
      • Sage Investigational Site
  • Washington
    • Bellevue, Washington, United States, 98007
      • Sage Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Participant has a diagnosis of MDD as diagnosed by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) Clinical Trial Version (SCID-5-CT), with symptoms that have been present for at least a 4-week period.
2. Participant is in good physical health and has no clinically significant findings, as determined by the Investigator, on physical examination, 12-lead electrocardiogram (ECG), or clinical laboratory tests.
3. Participant has a Montgomery-Åsberg Depression Rating Scale (MADRS) total score of ≥28 and a HAM-D total score of ≥20 at Screening and Day 1 (prior to dosing).

Exclusion Criteria:

1. Participant has attempted suicide associated with the current episode of MDD.
2. Participant has a medical history of bipolar disorder, schizophrenia, and/or schizoaffective disorder.
3. Participant has had vagus nerve stimulation, electroconvulsive therapy, or has taken ketamine (including esketamine) within the current major depressive episode.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SAGE-217	Drug: SAGE-217; SAGE-217

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part A: Number of Participants With Treatment Emergent Adverse Events (TEAEs)	An adverse event (AE) was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal (investigational) product whether or not related to the medicinal (investigational) product. For Part A, a TEAE was defined as an AE with onset after the first dose of SAGE-217.	Up to 52 Weeks
Part B: Number of Participants With TEAEs	An AE was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal (investigational) product whether or not related to the medicinal (investigational) product. For Part B, a TEAE was defined as an AE with onset on or after the first dose of SAGE-217 in MDD-303B for the participants who received placebo + ADT in parent study, or an AE with onset on or after the ICF signoff in MDD-303B for the participants who received SAGE-217 + ADT in parent study.	Up to 46 Weeks
Part A: Number of Participants With Suicidal Ideation (SI) or Suicidal Behavior (SB) as Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)	C-SSRS scale consisted of a baseline evaluation that assessed lifetime experience as well as past 24-month experience of participants for SI and SB and a postbaseline evaluation that focused on suicidality since last study visit. C-SSRS included "yes" or "no"' responses for assessment of SI and SB as well as numeric ratings for severity of ideation, if present. The C-SSRS SI items included: 1. wish to be dead, 2. non-specific active suicidal thoughts, 3. active SI with any methods, 4. active SI with some intent, and 5. active SI with a specific plan (5 being the most severe). C-SSRS SB items included 1. preparatory acts or behavior, 2. aborted attempt, 3. interrupted attempt, 4. actual attempt (non-fatal), and 5. completed suicide (5 being worst). Participants with at least one SI question answered Yes or at least one SB question answered Yes post-baseline for the specific period is counted under SI or SB respectively.	Baseline up to 52 Weeks (Study Period 1-5)
Part B: Number of Participants With Suicidal Ideation (SI) and Suicidal Behavior (SB) as Assessed by the C-SSRS	C-SSRS scale consisted of a baseline evaluation that assessed lifetime experience as well as past 24-month experience of participants for SI and SB and a postbaseline (PB) evaluation that focused on suicidality since last study visit. C-SSRS included "yes" or "no"' responses for assessment of SI and SB as well as numeric ratings for severity of ideation, if present. The C-SSRS SI items included: 1. wish to be dead, 2. non-specific active suicidal thoughts, 3. active SI with any methods, 4. active SI with some intent, and 5. active SI with a specific plan (5 being the most severe). C-SSRS SB items included 1. preparatory acts or behavior, 2. aborted attempt, 3. interrupted attempt, 4. actual attempt (non-fatal), and 5. completed suicide (5 being worst). Participants with at least one SI question answered Yes or at least one SB question answered Yes post-baseline for the specific period is counted under SI or SB respectively.	Baseline up to 46 Weeks (Study Period 1-5)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parts A and B: Time to First Repeat Treatment With SAGE-217	For Part A, the first day of the first repeat treatment is Treatment Cycle 2 Day 1. For Part B, participants who had "placebo + ADT" in the parent study (217-MDD-305), the first repeat treatment of SAGE-217 was the second treatment within MDD-303B. Participants who had SAGE-217 + ADT in the parent study (217-MDD-305), the first repeat treatment of SAGE-217 was the first treatment within MDD-303B. For Part A, as prespecified, data for this outcome measure was collected for Sage-217 High-dose Cohort and Sage-217 30 mg Cohort (Low Dose + Dose Switch). For Part B, data for this outcome measure is presented as per the designated arms in the parent study (217-MDD-305). Analysis used Kaplan-Meier estimates where the participants with no repeat treatment were censored.	Up to 52 Weeks
Parts A and B: Number of Participants Who Achieved the Requirements for Repeat Treatment for SAGE-217	Participants who continued in the study beyond 56 days from the last study drug dose (in parent study for Part B) and had a HAMD-17 total score ≥20 between the end of first treatment cycle and start of next treatment cycle qualified for repeat treatment for SAGE-217. The 17-item HAM-D was used for measuring severity of depression. It comprised individual ratings of following symptoms scored in a range of 0 to 2: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following symptoms were scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. The total score can range from 0 to 52, and higher scores indicated a greater degree of depression. For Part B, data for this outcome measure is presented as per the designated arms in the parent study (217-MDD-305).	Up to 52 Weeks
Parts A and B: Number of Repeat Treatment Cycles of SAGE-217 for Each Participant	The response of initial treatment and/or repeat treatment was assessed by HAMD-17. The 17-item HAM-D scale was used for measuring severity of depression. The HAM-D comprised individual ratings of following symptoms scored in range of 0 to 2: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. Following symptoms were scored in range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. total score range=0 to 52, and higher scores indicated greater degree of depression. Participants who had a HAM-D total score >=20 within the protocol were eligible for at least 1 repeat treatment in study. For Part B, data for this outcome measure is presented as per the designated arms in parent study (217-MDD-305). Participants who did not have any re-treatment were included with number of re-treatments equal to 0.	Up to 52 Weeks
Part A: Change From Baseline (CFB) in the HAMD-17 Total Score at Day 15 in Study Period 1	The 17-item HAM-D scale was used for measuring severity of depression. The 17-item HAM-D comprises individual ratings related to the following symptoms: depressed mood (sadness, hopeless, helpless, worthless), feelings of guilt, suicide, insomnia (early, middle, late), work and activities, retardation (slowness of thought and speech; impaired ability to concentrate; decreased motor activity), agitation, anxiety (psychic and somatic), somatic symptoms (gastrointestinal and general), genital symptoms, hypochondriasis, loss of weight, and insight. Each item is scored in a range of 0 to 2 or 0 to 4. The total score ranges from 0 to 52 with higher scores indicating a greater degree of depression. A negative change from baseline indicates improvement. A study period is a treatment cycle (treatment period+14-day follow-up) plus the observational period (until next treatment cycle or end of study, whichever is earlier) immediately following it.	Baseline, Day 15 in Study Period 1
Part A: Change From Baseline (CFB) in the HAMD-17 Total Score at Day 15 of Each Treatment Cycle	The 17-item HAM-D scale was used for measuring severity of depression. The 17-item HAM-D comprises individual ratings related to the following symptoms: depressed mood (sadness, hopeless, helpless, worthless), feelings of guilt, suicide, insomnia (early, middle, late), work and activities, retardation (slowness of thought and speech; impaired ability to concentrate; decreased motor activity), agitation, anxiety (psychic and somatic), somatic symptoms (gastrointestinal and general), genital symptoms, hypochondriasis, loss of weight, and insight. Each item is scored in a range of 0 to 2 or 0 to 4. The total score ranges from 0 to 52 with higher scores indicating a greater degree of depression. A negative change from baseline indicates improvement. Each 14-day treatment period plus corresponding 14-day follow-up period was considered a treatment cycle.	Baseline, Day 15 of treatment cycles 2, 3, 4, and 5
Part B: Change From Baseline in the HAMD-17 Total Score at Day 15 of Each Treatment (Initial and/or Repeat Treatment) Cycle	The 17-item HAM-D scale was used to measure the severity of depression. The 17-item HAM-D comprises individual ratings related to the following symptoms: depressed mood (sadness, hopeless, helpless, worthless), feelings of guilt, suicide, insomnia (early, middle, late), work and activities, retardation (slowness of thought and speech; impaired ability to concentrate; decreased motor activity), agitation, anxiety (psychic and somatic), somatic symptoms (gastrointestinal and general), genital symptoms, hypochondriasis, loss of weight, and insight. Each item is scored in a range of 0 to 2 or 0 to 4. The total score ranges from 0 to 52 with higher scores indicating a greater degree of depression. A negative change from baseline indicates improvement. Study period is defined as treatment cycle (28 days) followed by immediate observation period (maximum 46 weeks), until the first dose of the subsequent treatment cycle.	Baseline, Day 15 of Study Period 1, 2, 3, 4, and 5
Part A: Percentage of Participants Who Achieved HAM-D Response During Treatment Cycle 1	HAM-D response was defined as a ≥50% reduction in HAM-D score from baseline, at the end of each 14-day treatment period. The 17-item HAM-D scale was used for measuring severity of depression. The HAM-D comprised individual ratings of the following symptoms scored in a range of 0 to 2: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following symptoms were scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. The total score can range from 0 to 52, and higher scores indicated a greater degree of depression. Each 14-day treatment period plus corresponding 14-day follow-up period was considered a treatment cycle. Percentage are rounded off.	Day 15 of treatment cycle 1
Part A: Percentage of Participants Who Achieved HAM-D Response During Each Study Period	HAM-D response was defined as a ≥50% reduction in HAM-D score from baseline, at the end of each 14-day treatment period. The 17-item HAM-D scale was used for measuring severity of depression. The HAM-D comprised individual ratings of the following symptoms scored in a range of 0 to 2: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following symptoms were scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. The total score can range from 0 to 52, and higher scores indicated a greater degree of depression. A study period is a treatment cycle (treatment period+14-day follow-up) plus the observational period (until next treatment cycle or end of study, whichever is earlier) immediately following it. Percentage are rounded off.	Day 15 of Study Period 2, 3, 4, and 5
Part B: Percentage of Participants Who Achieved HAM-D Response	HAM-D response was defined as a ≥50% reduction in HAM-D score from baseline, at the end of each 14-day treatment period. The 17-item HAM-D scale was used for measuring severity of depression. The HAM-D comprised individual ratings of the following symptoms scored in a range of 0 to 2: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following symptoms were scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. The total score can range from 0 to 52, and higher scores indicated a greater degree of depression. A study period is defined as treatment cycle (28 days) followed by immediate observation period (maximum 46 weeks), until the first dose of the subsequent treatment cycle. Percentage are rounded off.	Day 15 of Study Period 1, 2, 3, 4, and 5
Part A: Percentage of Participants Who Achieved HAM-D Remission During Treatment Cycle 1	Remission was defined as having a HAM-D total score of ≤7. The 17-item HAM-D scale was used for measuring severity of depression. The HAM-D comprised individual ratings of the following symptoms scored in a range of 0 to 2: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following symptoms were scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. The total score can range from 0 to 52, and higher scores indicated a greater degree of depression. Each 14-day treatment period plus corresponding 14-day follow-up period was considered a treatment cycle. Percentage are rounded off.	Day 15 of treatment cycle 1
Part A: Percentage of Participants Who Achieved HAM-D Remission During Each Study Period	Remission was defined as having a HAM-D total score of ≤7. The 17-item HAM-D scale was used for measuring severity of depression. The HAM-D comprised individual ratings of the following symptoms scored in a range of 0 to 2: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following symptoms were scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. The total score can range from 0 to 52, and higher scores indicated a greater degree of depression. A study period is a treatment cycle (treatment period+14-day follow-up) plus the observational period (until next treatment cycle or end of study, whichever is earlier) immediately following it. Percentage are rounded off.	Day 15 of Study Periods 2, 3, 4, and 5
Part B: Percentage of Participants Who Achieved HAM-D Remission	Remission was defined as having a HAM-D total score of ≤7. The 17-item HAM-D scale was used for measuring severity of depression. The HAM-D comprised individual ratings of the following symptoms scored in a range of 0 to 2: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following symptoms were scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. The total score can range from 0 to 52, and higher scores indicated a greater degree of depression. A Study Period is defined as Treatment Cycle (28 days) followed by the immediate observational period (maximum 46 weeks), until the first dose of the subsequent treatment cycle. Percentage are rounded off.	Day 15 of Study Period 1, 2, 3, 4, and 5
Part A: Percentage of Participants Who Achieved Clinical Global Impression - Improvement (CGI-I) Response During Treatment Cycle 1	The CGI scale consists of 3 items. Only the first 2 items are being used in this study. The CGI-I employed a 7-point Likert scale to measure the overall improvement in the participant's condition posttreatment. The Investigator rated the participant's total improvement compared to baseline, whether or not it was due entirely to drug treatment. Response choices included: 0=not assessed, 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, and 7=very much worse. The CGI-I is only rated at posttreatment assessments. CGI-I response was defined as having a CGI-I score of "very much improved" or "much improved." Each 14-day treatment period plus corresponding 14-day follow-up period was considered a treatment cycle. Percentage are rounded off.	Day 15 of treatment cycle 1
Part A: Percentage of Participants Who Achieved CGI-I Response During Each Study Period	The CGI scale consists of 3 items. Only the first 2 items are being used in this study. The CGI-I employed a 7-point Likert scale to measure the overall improvement in the participant's condition posttreatment. The Investigator rated the participant's total improvement compared to baseline, whether or not it was due entirely to drug treatment. Response choices included: 0=not assessed, 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, and 7=very much worse. The CGI-I is only rated at posttreatment assessments. CGI-I response was defined as having a CGI-I score of "very much improved" or "much improved." A study period is a treatment cycle (treatment period+14-day follow-up) plus the observational period (until next treatment cycle or end of study, whichever is earlier) immediately following it. Percentage are rounded off.	Day 15 of Study Periods 2, 3, 4, and 5
Part B: Percentage of Participants Who Achieved CGI-I Response	The CGI scale consists of 3 items. Only the first 2 items are being used in this study. The CGI-I employed a 7-point Likert scale to measure the overall improvement in the participant's condition posttreatment. The Investigator rated the participant's total improvement compared to baseline, whether or not it was due entirely to drug treatment. Response choices included: 0=not assessed, 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, and 7=very much worse. The CGI-I is only rated at posttreatment assessments. CGI-I response was defined as having a CGI-I score of "very much improved" or "much improved." A Study Period is defined as Treatment Cycle (28 days) followed by the immediate observational period (maximum 46 weeks), until the first dose of the subsequent treatment cycle. Percentage are rounded off.	Day 15 of Study Period 1, 2, 3, 4, and 5
Part A: Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score During Treatment Cycle 1	The CGI-S uses a 7-point Likert scale to rate the severity of the participant's mental illness at the time of assessment, relative to the clinician's past experience with participants who had the same diagnosis. Considering total clinical experience, a participant was assessed on severity of mental illness at the time of rating as 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; and 7=extremely ill. A higher score indicated extreme illness. A negative change from baseline indicated improvement. Each 14-day treatment period plus corresponding 14-day follow-up period was considered a treatment cycle.	Baseline, Day 15 of treatment cycle 1
Part A: Change From Baseline in CGI-S Score During Each Treatment Cycle	The CGI-S uses a 7-point Likert scale to rate the severity of the participant's mental illness at the time of assessment, relative to the clinician's past experience with participants who had the same diagnosis. Considering total clinical experience, a participant was assessed on severity of mental illness at the time of rating as 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; and 7=extremely ill. A higher score indicated extreme illness. A negative change from baseline indicated improvement. Each 14-day treatment period plus corresponding 14-day follow-up period was considered a treatment cycle.	Baseline, Day 15 of treatment cycles 2, 3, 4, and 5
Part B: Change From Baseline in CGI-S Score	The CGI-S uses a 7-point Likert scale to rate the severity of the participant's mental illness at the time of assessment, relative to the clinician's past experience with participants who had the same diagnosis. Considering total clinical experience, a participant was assessed on severity of mental illness at the time of rating as 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; and 7=extremely ill. A higher score indicated extreme illness. A negative change from baseline indicated improvement. A Study Period is defined as Treatment Cycle (28 days) followed by the immediate observational period (maximum 46 weeks), until the first dose of the subsequent treatment cycle.	Baseline Day 15 of Study Period 1, 2, 3, 4, and 5

Collaborators and Investigators

• Sponsor: Biogen
• Collaborators: Biogen

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2019
• Primary Completion (Actual): June 22, 2023
• Study Completion (Actual): June 22, 2023

Study Registration Dates

• First Submitted: February 5, 2019
• First Submitted That Met QC Criteria: March 4, 2019
• First Posted (Actual): March 6, 2019

Study Record Updates

• Last Update Posted (Actual): August 27, 2024
• Last Update Submitted That Met QC Criteria: August 8, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major; Psychotropic Drugs; Antidepressive Agents; Zuranolone
• Other Study ID Numbers: 217-MDD-303

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No